& H AS HEALTH AND SAFETY AUTHORITY REACH and Downstream Users Marie McCarthy REACH GI Inspector Health and Safety Authority

& H AS HEALTH AND SAFETY AUTHORITY Am I a Downstream User ?

& H AS HEALTH AND SAFETY AUTHORITY Registration As it applies to Downstream Users (DUs)

& H AS HEALTH AND SAFETY AUTHORITY Registration - A Phased Process nNon-phase in Substances Registration required before manufacture/import/use nPhase-in Substances –3 years> 1000 t/yr CMRs Cat 1&2 >1 t/yr R50/53 > 100t/yr –6 years >100 t/yr –11 years > 1 t/yr

& H AS HEALTH AND SAFETY AUTHORITY Registration of Substances in Articles Required where  Substance is present at > 1 t/yr per producer or importer  Substance is intended to be released under normal or forseeable conditions Unless substance has already been registered for that use

& H AS HEALTH AND SAFETY AUTHORITY Notification of Substances in Articles Required where  Substance meets criteria in Art 54 and is identified according to Art 56(1)  Substance present at > 1 t/yr/M or I  Substance present at > 0.1% w/v Unless M/I can exclude exposure to humans & environment under normal & forseeable conditions of use.

& H AS HEALTH AND SAFETY AUTHORITY Low Volume (1-10 t/a) Substances Annex V testing required for  Non phase-in substances in all cases  Phase-in substances meeting one or both criteria in Annex I ( c ) -Likely to meet criteria for CMR Cat 1,2 or -Wide dispersive use and likely to be classified as dangerous Phase-in substances not meeting criteria in Annex I ( c ) only need physicochemical studies

& H AS HEALTH AND SAFETY AUTHORITY Tools used by Industry  CSA used to determine which risk management measures and operational conditions are necessary to ensure risks to human health and environment are adequately controlled  CSR used to document the appropriate risk management measures and operating conditions to ensure adequate control  Exposure scenario (ES) is a description of the set of conditions for use of a substance so that risks are adequately controlled. This must reflect the outcome of the CSA, be documented in the CSR and annexed to SDS  SDS used to communicate risk management measures downstream.

& H AS HEALTH AND SAFETY AUTHORITY Chemical Safety Assessment n CSA (Annex I) at > 10t/yr n Registrant must ensure that risks are adequately controlled for manufacture and/or each identified use n Must specify risk management measures for each exposure scenario n DU has a right to identify use to M/I n M/I includes this in his CSR if he can support the use n DU may choose not to identify use but may have to notifyChemicals Agency & perform CSA

& H AS HEALTH AND SAFETY AUTHORITY Exposure Scenario - conditions ensuring adequate control  Physicochemical characteristics  Process description  Operating conditions  Risk management measures  Populations exposed  Must cover entire life cycle including use in articles, consumer use, waste disposal etc.  Process-specific conditions >>>> broad, generic ESs covering multiple uses/substances

& H AS HEALTH AND SAFETY AUTHORITY Derivation of an Exposure Scenario Exposure Assessment Exposure Scenarios Existing Knowledge/data Classification and labelling Risk characterisation Adequate control Hazard Identification Hazard Assessment Exposure Scenarios (final) Documented in CSR and SDS

& H AS HEALTH AND SAFETY AUTHORITY Substance X in Paints for Brushing/Application by Roller Standardised exposure scenario for group of substances outlining Protective clothing Maximum periods of exposure Cleaning of brushes/rollers etc Disposal of waste

& H AS HEALTH AND SAFETY AUTHORITY Substance X used in Spray- painting of Cars Process- specific exposure scenario outlining Maximum periods of exposure Minimum requirements for the equipment (booth, breathing apparatus) Filtering efficiency Cleaning frequency and procedures Protective clothing Hygiene measures Waste disposal

& H AS HEALTH AND SAFETY AUTHORITY Is my use covered by my supplier’s registration ?

& H AS HEALTH AND SAFETY AUTHORITY Am I covered by Suppliers CSA ? DU Am I inside ES? SDS + Exposure Scenarios (ES) Apply ES No Notify Agency Do targeted CSA and CSR No Make use known to the supplier Yes

& H AS HEALTH AND SAFETY AUTHORITY Do I need to act? DU takes no further action in the following situations:  He is using less than 1 t/yr  He is operating within the conditions of an exposure scenario communicated via SDS and has implemented recommended RMM on his site  SDS not required for substance (e.g. not dangerous)  CSR not required for M/I ( e.g. < 10 tonnes/yr)  He is using it for PPORD

& H AS HEALTH AND SAFETY AUTHORITY I need to act The DU must complete a CSR and report to Agency in the following situations:  CSR required and  He is operating outside exposure scenario communicated in an SDS or  He has chosen to keep his use secret or M/I has not taken account of it  Methodology for DU CSA in Annex XI  Must implement appropriate Risk Management measures (RMM) on own site and inform DUs of appropriate RRM for their use

& H AS HEALTH AND SAFETY AUTHORITY DU Report  DU Report is not a registration  Limited information on identity of DU and supplier, identity of substance and generic use description  In limited circumstances, testing proposal may be required – dossier evaluation  Reporting not required for small quantities (< 1 tonne)

& H AS HEALTH AND SAFETY AUTHORITY Information Flow Through the Supply Chain

& H AS HEALTH AND SAFETY AUTHORITY Information flow through the Supply Chain  SDS main tool Extended scope & role  All dangerous substances and prepartions placed on the market  PBTs/vPvBs identified by Annex XII criteria  Must be consistent with CSA  Exposure scenarios annexed to SDS  Information flow up and down supply chain

& H AS HEALTH AND SAFETY AUTHORITY Roles for DUs under REACH  Check compliance with suppliers exposure scenario  If not covered, and where necessary, report to Agency and carry out a CSA  Comply with any authorisation and restriction conditions  Communication upstream & downstream

& H AS HEALTH AND SAFETY AUTHORITY Supports for DUs & SMEs  Guidance for downstream users (RIP 3.5)  Guidance on articles (RIP 3.8)  Tools for SMEs  Trade Associations - development of standardised use descriptions  National helpdesk – Health and Safety Authority  Agency helpdesk

& H AS HEALTH AND SAFETY AUTHORITY Benefits for DUs & SMEs  Improved access to information  Better quality of information  Informed decision-making  Improved worker safety  Reduced liability and compensation costs  Increased innovation

& H AS HEALTH AND SAFETY AUTHORITY Risks for SMEs and DUs  Increased costs  Withdrawl of substances  Disclosure of confidential business information

& H AS HEALTH AND SAFETY AUTHORITY Timelines  Nov 2005EP First Reading  Dec 2005Council political agreement  Autumn 2006Second Reading  2006/2007Development of IT tools and guidance for industry & MS  April 2007Entry into force  April 2008Agency operational. Registration and other provisions commence

& H AS HEALTH AND SAFETY AUTHORITY What should I do now ?  Monitor development of REACH and Guidance documents  Assess your use of chemicals  Think about implications of REACH for your business  Dialogue a.s.a.p!!!

& H AS HEALTH AND SAFETY AUTHORITY Useful Websites Commission Websites ch chemicals/reach ECB Websitehttp://ecb.jrc.it/ Health and Safety Authority Website Queries on REACH